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Effects of Solar Radiation on Human Function and Cognition

Primary Purpose

Heat Stress, Heat Strain

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Radiation and warm environment
Warm environment
Neutral environment with radiation
Neutral environment without radiation
Sponsored by
Petros Dinas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heat Stress focused on measuring heat stress, heat strain, solar radiation, responses, cognition, thermal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy non-smoker individuals who exercise at least three times per week

Exclusion Criteria:

  • Non healthy individuals and smokers

Sites / Locations

  • FAME Lab, Department of Exercise Science, University of Thessaly

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Hot environment with radiation

Hot environment without radiation

Neutral environment with radiation

Neutral environment without radiation

Arm Description

Exposure to hot environment (30°C WBGT) with radiation (800 W/m2) Exposure for 03:20:00: rest (two hours) work (cycling) at 100 W (one hour) recovery (twenty minutes)

Exposure to hot environment (30°C WBGT) with radiation (0 W/m2) Exposure for 03:20:00: rest (two hours) work (cycling) at 100 W (one hour) recovery (twenty minutes)

Exposure to neutral environment (20°C WBGT) with radiation (800 W/m2) Exposure for 03:20:00: rest (two hours) work (cycling) at 100 W (one hour) recovery (twenty minutes)

Exposure to neutral environment (20°C WBGT) with radiation (0 W/m2) Exposure for 03:20:00: rest (two hours) work (cycling) at 100 W (one hour) recovery (twenty minutes)

Outcomes

Primary Outcome Measures

Heart rate
Heart rate data were continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland
Mean skin temperature
Temperature at the skin surface area was continuously monitored using iButton sensors (type DS1921 H, Maxim/Dallas Semiconductor Corp., USA)
Core body temperature
Core body temperature was assessed throughout the entire protocol using telemetric capsules (e-Celsius, BodyCap, Caen, France) that was given to the workers to ingest prior to their work shift
Skin blood flow
Skin blood flow was measured throughout the entire protocol with a laser Doppler flowmeter (PeriFlux 4000, Perimed, Stockholm, Sweden) at right forearm (brachioradialis) and leg (gastrocnemius)
Sweat rate
Sweat rate was measured throughout the entire protocol at three regions [forehead, thigh (quadricep), and arm (bicep)] using ventilated capsule method
Perceived exertion
We used the Borg 20th Scale (6 = no exertion at all; 20 = maximal exertion)
Cognitive performance (Vigilance)
Vigilance was assessed via vigilance test. In this task two squares arranged vertically. A pattern jumps from one square to the other. Sometimes the pattern remains in one square. In this case volunteers had to touch the screen of a tablet computer as fast as possible. The total duration for the current task was set to 6 minutes. This is a well-known vigilance test described in the Test for Attentional Performance and previously used in the literature.
Thermal comfort
Thermal comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable).
Thermal sensation
Thermal sensation was assessed via the thermal sensation scale (-3 = cold; +3 = hot)
Cognitive performance (Divided Attention)
Divided attention task incorporates both auditory and visual stimuli in parallel. During the test a number of visual stimuli (crosses) appear in a random configuration in a 4X4 matrix. At the same time volunteers hear high and low beeps in a random order. The task is to detect whether crosses form a square and at the same time two high or low beeps are emitted twice in a row. This is a well-known vigilance test described in the Test for Attentional Performance and previously used in the literature.
Cognitive performance (Memory Test)
This is a computerized version of Sternberg's memory task. In this task volunteers had to observe carefully a random sequence of one to six digits (0 to 9) painted in white and displayed for 1.2 seconds each. Thereafter, a two second delay was followed by a random test digit filled in yellow color. Participants had to response as fast as possible by pressing "yes" or "no" button to indicate where the yellow digit appeared in the previous sequence or not, respectively. In this test participants were tested in 24 trials.
Cognitive performance (Reaction Time)
In this task participants had to respond as quickly as possible, by untouching the screen, after receiving a visual or acoustic stimulus.

Secondary Outcome Measures

Full Information

First Posted
November 7, 2019
Last Updated
November 9, 2019
Sponsor
Petros Dinas
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1. Study Identification

Unique Protocol Identification Number
NCT04160741
Brief Title
Effects of Solar Radiation on Human Function and Cognition
Official Title
Effects of Solar Radiation on Human Function and Cognition
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
May 27, 2019 (Actual)
Study Completion Date
May 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Petros Dinas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Solar radiation is a physical phenomenon which interacts with any human being throughout its life on earth. This interaction is associated with numerous physiological functions, as well as a broad spectrum of deleterious effects on human health and wellbeing. The aim of this study is to elucidate the effects of solar radiation on human function and cognition in environmental conditions characterized by the same thermal stress.
Detailed Description
Volunteers were exposed to four different environmental conditions [two hot environments: 30°C WBGT (1st: air temperature = 32.6°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 800 W/m2 and 2nd. air temperature = 40.6°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 0 W/m2) and two neutral environments: 20°C WBGT (1st: air temperature = 19.1°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 800 W/m2 and 2nd. air temperature = 28.5°C; relative humidity = 30%; wind speed = 0.5 m/s; solar radiation = 0 W/m2], over an equal number of days. The aforementioned environmental scenarios were randomly allocated for each volunteer. To minimize participant bias, the true purpose of the study was hidden from the volunteers. Of course, once the data collection was completed, all volunteers were informed about the true purpose of the study and gave their permission to analyze and publish these data. During this blinded randomized controlled trial, all volunteers participated four times in an experimental protocol with a total duration of 03:20:00, following an hour of preparation and baseline tests. The protocol had three main time periods [rest (two hours), work (cycling) at 100 W (one hour), and recovery (twenty minutes)]. Anthropometrical data [age; body stature (Seca 213; seca GmbH & Co. KG; Hamburg, Germany); body mass (BC1000, Tanita corporation, Tokyo, Japan); body fat (DXA scan: Lunar DPX Madison, GE Healthcare, Wisconsin, USA); and lean mass (DXA scan: Lunar DPX Madison, GE Healthcare, Wisconsin, USA)] were collected two days prior to the experiments. Volunteers were euhydrated prior to the experiments. Hydration status was assessed using a handheld refractometer (ATAGO Ltd, Tokyo, Japan) and determined as either euhydrated (USG < 1.020) or dehydrated (USG ≥ 1.020) according to the current guidelines. Water consumption was restricted during the experimental protocol. The same clothing consisting of a light-blue t-shirt (100% cotton), a black exercise short pant (100% polyester), and a pair of medium-high socks (100% cotton) were used by volunteers throughout the experiments. A pair of sunglasses was mandatory to be worn throughout the experiments. Furthermore, experiments took place during the same hour of the day for each participant and an 8-hour fasting was ensured prior to the experiments. Furthermore, participants were requested to avoid caffeine and alcohol consumption for at least twelve hours before the experiments, as well as to avoid salt and sugar consumption eight hours before the experiments. During the study, continuous heart rate, core temperature, mean skin temperature, skin blood flow, and sweat rate were measured. Specifically, heart rate was collected using wireless heart rate monitors (Polar Team2. Polar Electro Oy, Kempele, Finland). Core temperature was collected using telemetric capsules (BodyCap, Caen, France). Skin temperature from four sites was measured using wireless thermistors (iButtons type DS1921H, Maxim/Dallas Semiconductor Corp., USA) and was expressed as mean skin temperature according to Ramanathan [mean skin temperature = 0.3(chest + arm) + 0.2(thigh + leg). Skin blood flow was measured with a laser Doppler flowmeter (PeriFlux 4000, Perimed, Stockholm, Sweden) at right forearm (brachioradialis) and leg (gastrocnemius). The probe (PROBE 413 Integrating Probe, Perimed, Stockhold, Sweden) was held in place with a plastic holder (PH 13, Perimed, Stockhold, Sweden). Sweat rate was measured at three regions [forehead, thigh (quadricep), and arm (bicep)] using ventilated capsule method. Thermal comfort (1 = comfortable; 5 = extremely uncomfortable), thermal sensation (-3 = cold; +3 = hot), and perceived exertion (6 = no exertion at all; 20 = maximal exertion), alongside cognitive performance (vigilance, divided attention, memory test, and reaction time) were assessed at baseline, pre work condition (01:40:00), and post work (03:00:00) conditions. Volunteers entered the chamber five minutes prior to the experiments to install data loggers and accompanied sensors on their body.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heat Stress, Heat Strain
Keywords
heat stress, heat strain, solar radiation, responses, cognition, thermal

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hot environment with radiation
Arm Type
Experimental
Arm Description
Exposure to hot environment (30°C WBGT) with radiation (800 W/m2) Exposure for 03:20:00: rest (two hours) work (cycling) at 100 W (one hour) recovery (twenty minutes)
Arm Title
Hot environment without radiation
Arm Type
Experimental
Arm Description
Exposure to hot environment (30°C WBGT) with radiation (0 W/m2) Exposure for 03:20:00: rest (two hours) work (cycling) at 100 W (one hour) recovery (twenty minutes)
Arm Title
Neutral environment with radiation
Arm Type
Experimental
Arm Description
Exposure to neutral environment (20°C WBGT) with radiation (800 W/m2) Exposure for 03:20:00: rest (two hours) work (cycling) at 100 W (one hour) recovery (twenty minutes)
Arm Title
Neutral environment without radiation
Arm Type
Active Comparator
Arm Description
Exposure to neutral environment (20°C WBGT) with radiation (0 W/m2) Exposure for 03:20:00: rest (two hours) work (cycling) at 100 W (one hour) recovery (twenty minutes)
Intervention Type
Other
Intervention Name(s)
Radiation and warm environment
Intervention Description
Exposure to hot environment (30°C WBGT) with radiation (800 W/m2) Exposure for 03:20:00: rest (two hours) work (cycling) at 100 W (one hour) recovery (twenty minutes)
Intervention Type
Other
Intervention Name(s)
Warm environment
Intervention Description
Exposure to hot environment (30°C WBGT) with radiation (0 W/m2) Exposure for 03:20:00: rest (two hours) work (cycling) at 100 W (one hour) recovery (twenty minutes)
Intervention Type
Radiation
Intervention Name(s)
Neutral environment with radiation
Intervention Description
Exposure to neutral environment (20°C WBGT) with radiation (800 W/m2) Exposure for 03:20:00: rest (two hours) work (cycling) at 100 W (one hour) recovery (twenty minutes)
Intervention Type
Other
Intervention Name(s)
Neutral environment without radiation
Intervention Description
Exposure to neutral environment (20°C WBGT) with radiation (0 W/m2) Exposure for 03:20:00: rest (two hours) work (cycling) at 100 W (one hour) recovery (twenty minutes)
Primary Outcome Measure Information:
Title
Heart rate
Description
Heart rate data were continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland
Time Frame
03 hours and 20 minutes
Title
Mean skin temperature
Description
Temperature at the skin surface area was continuously monitored using iButton sensors (type DS1921 H, Maxim/Dallas Semiconductor Corp., USA)
Time Frame
03 hours and 20 minutes
Title
Core body temperature
Description
Core body temperature was assessed throughout the entire protocol using telemetric capsules (e-Celsius, BodyCap, Caen, France) that was given to the workers to ingest prior to their work shift
Time Frame
03 hours and 20 minutes
Title
Skin blood flow
Description
Skin blood flow was measured throughout the entire protocol with a laser Doppler flowmeter (PeriFlux 4000, Perimed, Stockholm, Sweden) at right forearm (brachioradialis) and leg (gastrocnemius)
Time Frame
03 hours and 20 minutes
Title
Sweat rate
Description
Sweat rate was measured throughout the entire protocol at three regions [forehead, thigh (quadricep), and arm (bicep)] using ventilated capsule method
Time Frame
03 hours and 20 minutes
Title
Perceived exertion
Description
We used the Borg 20th Scale (6 = no exertion at all; 20 = maximal exertion)
Time Frame
Participants were assessed at baseline and every half an hour up until the end of the protocol at "hour 3".
Title
Cognitive performance (Vigilance)
Description
Vigilance was assessed via vigilance test. In this task two squares arranged vertically. A pattern jumps from one square to the other. Sometimes the pattern remains in one square. In this case volunteers had to touch the screen of a tablet computer as fast as possible. The total duration for the current task was set to 6 minutes. This is a well-known vigilance test described in the Test for Attentional Performance and previously used in the literature.
Time Frame
Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".
Title
Thermal comfort
Description
Thermal comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable).
Time Frame
Participants were assessed at baseline and every half an hour up until the end of the protocol at "hour 3".
Title
Thermal sensation
Description
Thermal sensation was assessed via the thermal sensation scale (-3 = cold; +3 = hot)
Time Frame
Participants were assessed at baseline and every half an hour up until the end of the protocol at "hour 3".
Title
Cognitive performance (Divided Attention)
Description
Divided attention task incorporates both auditory and visual stimuli in parallel. During the test a number of visual stimuli (crosses) appear in a random configuration in a 4X4 matrix. At the same time volunteers hear high and low beeps in a random order. The task is to detect whether crosses form a square and at the same time two high or low beeps are emitted twice in a row. This is a well-known vigilance test described in the Test for Attentional Performance and previously used in the literature.
Time Frame
Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".
Title
Cognitive performance (Memory Test)
Description
This is a computerized version of Sternberg's memory task. In this task volunteers had to observe carefully a random sequence of one to six digits (0 to 9) painted in white and displayed for 1.2 seconds each. Thereafter, a two second delay was followed by a random test digit filled in yellow color. Participants had to response as fast as possible by pressing "yes" or "no" button to indicate where the yellow digit appeared in the previous sequence or not, respectively. In this test participants were tested in 24 trials.
Time Frame
Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".
Title
Cognitive performance (Reaction Time)
Description
In this task participants had to respond as quickly as possible, by untouching the screen, after receiving a visual or acoustic stimulus.
Time Frame
Participants were assessed at baseline, at 1 hour and 40 minutes, and at "hour 3".

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy non-smoker individuals who exercise at least three times per week Exclusion Criteria: Non healthy individuals and smokers
Facility Information:
Facility Name
FAME Lab, Department of Exercise Science, University of Thessaly
City
Tríkala
State/Province
Thessaly
ZIP/Postal Code
42100
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Solar Radiation on Human Function and Cognition

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